The Biocidal Products Regulation

This conference has become an important international meeting for producers, importers and downstream users of biocidal products. It will be providing information on the current regulatory developments as well as on the implementation of the BPR in the various EU member states.

17.04. — 18.04.2024
Atrium Hotel Mainz
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Übersicht

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For many years, the Akademie Fresenius Conference “The Biocidal Products Regulation” has been the perfect platform for bringing together the regulatory, industrial and consulting communities. We therefore cordially invite you to join the next Conference. Plenty of exciting presentations are awaiting you!

Highlights

Regulatory and Scientific Challenges under the BPR

  • Update from ECHA
  • ED assessment of biocidal products and co-formulants
  • Challenges with dietary risk assessment of biocides
  • Biocidal Product Families: Experience with implementation and application of the revised BPF concept
  • Experiences with Simplified Authorisation of biocidal products: Regulatory procedure and data requirements

Legal Developments

  • What are the consequences of Article 95 breach?
  • Legal Update and jurisdiction: A comprehensive overview of the most recent relevant legal developments

Sustainability and Animal Welfare

  • The Germany BfR on Biocides and the European sustainability initiatives
  • New Approach Methodologies (NAMs) for adult and developmental neurotoxicity

Who should attend this conference?

Professionals working in the fields of:

  • Legal and regulatory affairs
  • Registration and authorisation
  • Research and development
  • Product safety
  • Product management
  • Regulatory science

Sectors that should take part:

  • Biocides and chemical industry
  • Producers of biocidal products
  • Industrial, professional and downstream users of biocides
  • Regulatory authorities
  • Research institutes
  • Legal and technical consultancies
  • Professional associations

Picture Credit: © Gman73 - fotolia.com, Jacek Fulawka - shutterstock.com

 

Programm

PLEASE NOTE: The indicated times refer to Central European Time CEST.

For further time zones, please view here.



Wednesday, 17 April 2024


Morning Session | 09:30 – 13:05 CEST
09:00
Registration and coffee
09:30
Welcome address by the organisers and the Chairs

Michael Werner, Arrow Regulatory, Austria
Cindy van der Meer, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands



Regulatory Update & Current Challenges
09:40
Update from ECHA and new IT tools for submitting your Summary of Product Characteristics (SPC)

Roberto Gilioli, European Chemicals Agency, Finland

10:15
ED assessment of biocidal products and coformulants – cross talk between biocides and REACH
from the point of view of a competent authority
  • ED assessment for biocidal products
  • ED assessment outcome and biocidal product authorisation

Carina Bos, Board for the Authorisation of Plant Protection Products and Biocides (Ctbg), The Netherlands

10:50
Challenges associated with active substance applications and renewals under the BPR: Consultancy point of view
  • Different types of active substance applications under the BPR and associated challenges
  • Data generation, data sharing and legal aspects
  • Evaluation of potential endocrine disrupting properties
  • Lessons from (pre-submission) discussions with evaluating competent authorities (eCAs)

An Vanden Bosch, Arche Consulting, Belgium

11:25
Coffee break
11:55
Challenges in the Dietary Risk Assessment of Biocides – Update from a practical point of view

Michael Werner, Arrow Regulatory, Austria

12:30
Data protection and the Review Programme: An unjustifiable disconnection of the end-dates
  • Historic error that needs fixing
  • Free-riding on the horizon

Boris Van Berlo, European Chemical Industry Council (Cefic), Belgium

13:05
Lunch break


Afternoon Session | 14:30 – 17:30 CEST
14:30
Biocidal Product Families: Experience with implementation and application of the revised BPF concept of July 2019

Tilo Walther, Federal Office for Chemicals (BfC), Federal Institute for Occupational Safety and Health (BAUA), Germany

15:05
Biocidal Product Families – Experiences and challenges from an Industry point of view
  • Managing a large portfolio – Rationalisation
  • Dealing with Substances of Concern (SoC)
  • Strategical decisions

Fabien Rouessay, Redebel Regulatory Affairs, Belgium

15:40
Coffee break
16:15
Experiences with Simplified Authorisation of biocidal products: Regulatory procedure and data requirements
  • Regulatory background and procedure
  • Requirements and guidance
  • Experience

Lonne Gerritsen and Carolina Vieira, knoell, Germany

17:00
Final Discussion
17:30
End of the first conference day
17:30
Evening event
After the first conference day you are most welcome to attend our evening event for an unhurried evening of good food and leisure time. Please, join us to continue the day’s interesting discussions in a relaxed and comfortable atmosphere.


Thursday, 18 April 2024

PLEASE NOTE: The indicated times refer to Central European Time CEST.

For further time zones, please view here.



Morning Session | 09:30 – 13:35 CEST
09:30
Brief address by the Chairs

Michael Werner, Arrow Regulatory, Austria
Cindy van der Meer, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands



Legal Developments
9:40
Enforcement of Article 95

Eugen Anwander, Institute for Environment and Food Safety, Vorarlberg State Service / Vice Chair of the BPR Subgroup in ECHA‘s Enforcement Forum, Austria

10:05
Biocides Enforcement from a legal perspective
on new projects
  • Results from completed enforcement projects and outlook
  • Current case law and key findings from legal practice
  • Additional enforcement risks due to new and upcoming legislation

Martin Ahlhaus, Produktkanzlei, Germany

10:40
Legal Update and jurisdiction: A comprehensive overview of the most recent relevant legal developments

Henning Krüger, ChemLaw, Germany

11:25
Coffee break


Sustainability & NAMs
11:55
Biocides and the European sustainability initiatives: challenges from an authority point of view

Vera Ritz, Federal Institute vor Risk Assessment (BfR), Germany

12:30
New Approach Methodologies (NAMs) for adult and developmental neurotoxicity: State of the science and road to regulatory implementation

Ellen Fritsche, Swiss Centre for Applied Human Toxicology (SCAHT), Switzerland

13:05
Summary and final discussion
13:35
Lunch and end of the conference

Referent:innen

 

Name

Unternehmen

Ahlhaus

Martin Ahlhaus

Produktkanzlei

Martin Ahlhaus is a lawyer and partner at the law firm “Produktkanzlei”. He specializes in questions related to chemicals and substance regulations (including REACH, CLP, BPR, POP) as well as product-related environmental law. With respect to the BPR, he advises companies from various sectors on Product Compliance and Product Stewardship projects. He represents multiple consortia established for active substance approval and/or biocidal product authorisation. Additionally, he represents companies in relevant regulatory and judicial proceedings at national and European level.

mehrweniger
Anwander

Eugen Anwander

Institute for Environment and Food Safety, Vorarlberg State Service, Austria/ Vice Chair of the BPR Subgroup in ECHA's Enforcement Forum, Finland

Eugen Anwander has been employed at the Federal State Government Service Vorarlberg in the Institute for Environment and Food Safety and the Chemical Safety Unit since 1992. Being a chemical inspector, he is currently the Vice-Chair of the Biocidal Products Regulation Subgroup within the ECHA Enforcement Forum.

mehrweniger
Bos

Carina Bos

Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands

Carina Bos is European Registered Toxicologist and works as a Senior Scientific Assessor Human Toxicology at the Dutch Ctgb. She has collected experience with the Biocidal Products Regulation for over 14 years, both at active substance level and at biocidal product authorisation level.

mehrweniger
Fritsche

Ellen Fritsche

Swiss Centre for Applied Human Toxicology (SCAHT), Switzerland

Ellen Fritsche, MD, is habilitated for Environmental Toxicology and is the new Director of the Swiss Centre for Applied Human Toxicology (SCAHT) in Basel. She previously held a professorship at the Heinrich-Heine-University Dusseldorf in a joint appointment as a Group Leader position at the IUF - Leibniz Research Institute for Environmental Medicine in Düsseldorf. Her lab has been developing and scientifically validating new approach methods (NAMs) for developmental (DNT) and adult neurotoxicity. She is part of an international consortium involving EFSA and the OECD that set up a DNT in vitro battery (IVB) for regulatory purposes and was involved in the preparation of the OECD recommendations on use and interpretation of this DNT IVB. She is actively involved in the H2020 and Horizon Europe projects on regulatory toxicology, PARC, ENTpoiNTs, ONTOX, CHIASMA and the EFSA projects Brain Health and DNT-RAP.

mehrweniger
Gerritsen

Lonne Gerritsen

knoell NL, The Netherlands

Lonne Gerritsen has a background in plant protection research. From 2007 to 2018 she worked for the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) as an expert on efficacy of biocides. She was a member of the ECHA BPR WG on efficacy and was involved in the preparation of efficacy guidance over the years. In 2018, she started working for Knoell in the Netherlands as a consultant in regulatory affairs and efficacy expert for biocides. In her current role at Knoell, Lonne is part of Knoell’s efficacy task force and supports clients with her expertise in the efficacy and regulatory area.

mehrweniger
Gilioli

Roberto Gilioli

European Chemicals Agency (ECHA), Finland

Roberto Gilioli started working in ECHA in 2008 and he is currently leading the Team in the Biocidal Products Unit which manages the development of Biocides IT tools, coordinates the updates of guidance documents and provides support to the organisation of meetings relevant for BPR processes.Before joining Biocides, he has been working in ECHA as risk manager in the context of REACH authorisation processes. A Chemical Engineer by degree, he has post-graduate qualifications in environmental management and economics and he also holds an executive master in business administration.

mehrweniger
Krüger

Henning Krüger

ChemLaw

Henning Krüger is a lawyer at the Dortmund-based law firm ChemLaw, specialised on chemical regulations (BPR, REACH, CLP, Cosmetics etc.). He advises companies from production and trade on product compliance and product stewardship projects and in connection with the drafting of contracts in the supply chain. He also represents companies in corresponding regulatory and judicial proceedings at national and European level and in competition law disputes with competitors. Having worked for several years as the responsible lawyer for the Federal Chemicals Agency at the German Federal Institute for Occupational Safety and Health (BAuA), Henning is very familiar with all issues of European and national chemicals law.

mehrweniger
Ritz

Vera Ritz

Federal Institute for Risk Assessment (BfR), Germany

Vera Ritz is Head of the Unit „Steering and Overall Assessment Biocides“ in the Department „Pesticides Safety“ at the Federal Institute for Risk Assessment (BfR) in Berlin. She has been working at the BfR since 2006 and is involved in assessments, conceptual and research activities regarding EDs.

mehrweniger
Rouessay

Fabien Rouessay

Redebel Regulatory Affairs, Belgium

Fabien Rouessay spent about 15 years in the chemical industry and more specifically in the biocidal regulation area before joing Redebel Regulatory Affairs five years ago. Here he is a project and consortium manager: In addition to providing support during the whole dossier preparation process, he assists applicants in defending their dossiers throughout assessment challenging period also by representing them at meetings with competent authorities.

mehrweniger
Van Berlo

Boris Van Berlo

European Chemical Industry Council (Cefic), Belgium

Boris Van Berlo has a PhD in catalysis from the KU Leuven. His biocides journey started 14 years ago at the Belgian Competent Authority. In 2019 he joined Biocides For Europe, a sector group of the European Chemical Industry Council (Cefic) where he currently leads the biocides team.

mehrweniger
Vanden Bosch

An Vanden Bosch

Arche Consulting, Belgium

An Vanden Bosch holds a PhD in medical sciences and is a certified European Registered Toxicologist (ERT). At ARCHE Consulting, she provides regulatory assistance to clients in the biocides and crop protection industry.

mehrweniger

Carolina Vieira

knoell, Germany

Carolina Vieira joined knoell Germany, where she works as a Regulatory Chemist, in 2017. Currently she is involved mainly in different Biocide projects (Biocidal product authorizations, Biocidal Product Families, Active Substance Renewals etc.), focusing on physicochemical properties, physical hazards and analytical methods, supporting clients with their dossier registrations. She studied Chemistry (Msci) and Environmental Science (Msc). She is an Associated Member of the Royal Society of Chemistry.

mehrweniger

Thilo Walther

Federal Institute for Occupational Safety and Health (BAuA), Germany

Thilo Walther joined the German BAuA in 2009 after studying chemistry and obtaining his PhD at the Max-Planck Institute in Dortmund. He was member of the working party, which developed the new BPF guidance.

mehrweniger
Werner

Michael Werner

Arrow Regulatory, Austria

van der Meer

Cindy van der Meer

Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands

Cindy van der Meer is currently Account Manager Biocides and Team Leader of the team Service Desk & Project Support at the dutch Ctgb, which she joined in 2010. As Account Manager she is the first point of contact for companies wishing to apply for a biocides registration at the Ctgb. Cindy has a PhD in Medical Biology.

mehrweniger

Veranstaltungsort

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Flugplatzstr. 44
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Inhalt und Konzeption

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amoeller@akademie-fresenius.de

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Organisation und Teilnehmermanagement

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